- The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
- Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
- For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
- Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
- Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
- Formulate tablets that are uniform in weight and drug content
- Manufacture bioavailable products according to indication requirements
- Create chemically and physically stable tablets that last over long periods
- Formulate products that are free of defects and have an elegant finish
The most common tablet manufacturing process techniques include:
A method commonly used for compressed tablet production, wet granulation involves a size enlargement process and an adhesive substance known as binder. Manufacturing tablets using the wet granulation technique increases the chances of meeting all physical requirements for tablet formation.
Here are the steps for a successful wet granulation tablet manufacturing process:
- Weigh, mill, and mix your active pharmaceutical ingredients APIs with powdered excipients.
- Prepare the binder solution.
- Mix your binder solution with powders to create a damp mass.
- Wet screen the dampened powder into pellets or granules using a mesh screen.
- Dry the moist granules.
- Use dry screening to size granulation.
- Mix the dried granules with lubricant and disintegrants.
- Compress the granules into tablets.
The dry granulation tablet manufacturing process works by compacting powder mixtures into large pieces or compacts and breaking them down into granules. Dry granulation is typically used when tablet excipients have sufficient, inherent binding properties. Dry granulation can also be used to prevent drug substance exposure to elevated temperatures during drying or moisture. The dry granulation tablet manufacturing process eliminates several manufacturing steps but still requires weighing, mixing, slugging, dry screening, lubrication, and granule compression.
Here are the steps for a successful dry granulation tablet manufacturing process:
- Weigh and mill formulation ingredients like drug substances and excipients.
- Mix the milled powders.
- Compress the mixed powders into slugs.
- Mill and sieve the slugs.
- Compress them into tablets.
The direct compression tablet manufacturing process directly compresses powdered materials into tablets without modifying physical properties. Using the direct compression tablet manufacturing process is a cost-effective way to develop tablets, and it’s a common solution for producing generic products in the pharmaceutical industry. Direct compression also avoids a wide range of wet and dry granulation problems.
Here are the steps for a successful direct compression tablet manufacturing process:
- Mill therapeutic agents and excipients.
- Mix the milled powders, disintegrants, and lubricants.
- Compress the tablets.
Several factors influence choosing the right tablet manufacturing process:
- The compression properties of your API
- The physical and chemical stability of the API during the manufacturing process
- The formulation ingredients’ particle size
- The availability of required processing equipment
- The cost to manufacture
There is a wide variety of pharma tablet machines specifically used in the tablet manufacturing process:
Common size reduction equipment used in tablet manufacturing includes a variety of milling equipment like hammer mills, vibration mills, pin mills, end-runner mills, edge-runner mills, cutter mills, and ball mills.
Weighing balance equipment used in tablet manufacturing is used to get the precise weight of your tablets and is available in bulk and electronic weighing balance systems.
Granulators are used in tablet manufacturing to create wet or dry tablet granules. Granulator machines commonly used today include rotating shape granulators, mechanical agitator granulators, high-shear granulators, fluidized-bed granulators, and dry granulators.
A wide range of mixing equipment is used in tablet manufacturing to mix powders and ingredients accurately. The most common machinery available includes pneumatic mixers, diffusion mixers, convective mixers, ribbon blenders, orbiting screw mixers, horizontal blenders, and planetary blenders.
During tablet manufacturing, drying equipment reduces moisture in pharmaceutical powders and granules. Popular machinery for drying tablets includes spray dryers, rotary dryers, and fluidized-bed dryers.
Tableting machinery, also known as tablet presses, is used to compress pharmaceutical powder into tablets that are uniform in shape, size, and weight. Many manufacturers used high-speed rotary tablet machines and multi-layer rotary tablet presses for quality tablet compression.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality:
Capping occurs during the tablet manufacturing process, but it’s often not discovered until coating, resulting in broken tablet pieces or bumps reflected in the coating.
A common cause of tablet chipping is excessive attrition during the coating process.
Sticking and picking are common problems in tablet manufacturing that can happen for several reasons, like poor tablet quality and over-wetting or under-drying the tablets.
With the right process and machine in place, these common defects can be prevented.
At Thomas Processing, we offer high-quality tablet coating systems to help you with that final step before packaging: coating your tablets. Thomas’s tablet coating systems have advanced designs to offer you an improved good manufacturing process (GMP) that eliminates material waste and reprocessing during start-up and shutdown. During design, we follow modern GMP guidelines, including using fewer screws, implementing removeable equipment parts to improve cleanability, and manufacturing smaller equipment to reduce production plant GMP space requirements. Contact us today to learn more about how we can help you with the final stage of your tablet manufacturing process.